Expanded Hernia Mesh Patch Recall

February 2007

The Food and Drug Administration (FDA) announced an expanded recall of the Bard Composix Kugel Mesh Patches that were originally recalled in December 2005. The patches were used to repair ventral hernias caused by thinning or stretching of scar tissue that formed after surgery.

The patch was recalled in December 2005 because the “memory recoil ring” that holds the patch open could break under stress, leading to bowel perforations and chronic intestinal fistulae. The list has since been expanded and is shown below in its entirety.

Recalled product codes and lot numbers include:

• 0010206- Lot numbers manufactured before January 2006
• 0010207- Lot numbers manufactured before January 2006
• 0010208- Lot numbers manufactured before January 2006
• 0010209- Lot numbers manufactured before March 2006
• 0010202- Lot numbers manufactured before October 2005
• 0010204- Lot numbers manufactured before October 2005

Patients who have one of the recalled patches should seek medical attention immediately if they experience symptoms associated with ring breakage. Symptoms include unexplained or persistent abdominal pain, fever, and tenderness at the implant site. For more information, customers should contact Davol customer service at 1-800-531-4124.